1932

Abstract

The US Supreme Court's recent decision in declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, “products of nature” were not eligible to be patented unless they were “isolated and purified” from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply patent-law logic to genes themselves. These patents, along with other biological patents, generated substantial social and political criticism. Myriad Genetics, a company with patents on and , two genes critical to assessing early-onset breast and ovarian cancer risk, and with a particularly controversial business approach, became the antagonist in an ultimately successful campaign to overturn gene patents in court. Despite Myriad's defeat, some questions concerning the rights to monopolize genetic information remain. The history leading to that defeat may be relevant to these future issues.

Loading

Article metrics loading...

/content/journals/10.1146/annurev-genet-112414-054731
2015-11-23
2024-03-29
Loading full text...

Full text loading...

/deliver/fulltext/genet/49/1/annurev-genet-112414-054731.html?itemId=/content/journals/10.1146/annurev-genet-112414-054731&mimeType=html&fmt=ahah

Literature Cited

  1. 1.  35 US Code § 102
  2. 2.  35 US Code § 112
  3. Adams MD, Kelley JM, Gocayne JD, Dubnick M, Polymeropoulos MH. 3.  et al. 1991. Complementary DNA sequencing: expressed sequence tags and Human Genome Project. Science 252:1651–56 [Google Scholar]
  4. Allison JR, Lemley MA, Moore KA, Trunkey RD. 4.  2004. Valuable patents. Georget. Law J. 92:435–77 [Google Scholar]
  5. Andrews LB, Paradise J. 5.  2005. Gene patents: the need for bioethics scrutiny and legal change. Yale J. Health Policy Law Ethics 5:403–12 [Google Scholar]
  6. 6. Association for Molecular Pathology v. Myriad Genetics 2011. 653 F.3d 1329 (Fed. Cir.)
  7. 7. Association for Molecular Pathology v. Myriad Genetics, Inc. 2012. 132 S. Ct. 1794
  8. 8. Association for Molecular Pathology v. Myriad Genetics, Inc. Petition for Certiorari. 2012. 2013 West Law 1850746
  9. 9. Association for Molecular Pathology v. Myriad Genetics Brief for Amicus Curiae Eric S. Lander in Support of Neither Party. 2013. https://www.wsgr.com/PDFSearch/lander.pdf
  10. 10. Association for Molecular Pathology v. Myriad Genetics, Inc. 2013. 133 S. Ct. 2107
  11. 11. Association for Molecular Pathology v. US Patent and Trademark Office 2010. 702 F. Supp. 2d 181 (S.D.N.Y.)
  12. Baltimore D. 12.  1970. RNA-dependent DNA polymerase in virions of RNA tumour viruses. Nature 226:1209–11 [Google Scholar]
  13. Barfield C, Calfee JE. 13.  2007. Biotechnology and the Patent System: Balancing Innovation and Property Rights Washington, DC: Am. Enterp. Inst. Press
  14. Barton JH. 14.  2002. Research-tool patents: Issues for health in the developing world. Bull. WHO 80:2121–25 [Google Scholar]
  15. Beauchamp C. 15.  2013. Patenting nature: a problem of history. Stanf. Technol. Law Rev. 16:257–312 [Google Scholar]
  16. Burk DL. 16.  2014. The curious incident of the Supreme Court in Myriad Genetics. Notre Dame Law Rev. 90:505–542 [Google Scholar]
  17. Burk DL, Lemley MA. 17.  2002. Is patent law technology specific?. Berkeley Technol. Law J. 17:1155–206 [Google Scholar]
  18. Burrows B. 18.  1997. Campaigns against life patenting. Synthesis/Regeneration 14: http://www.greens.org/s-r/14/14-18.html [Google Scholar]
  19. Cann HM, de Toma C, Cazes L, Legrand M-F, Morel V. 19.  et al. 2002. A human genome diversity cell line panel. Science 296:61–62 [Google Scholar]
  20. Cavalli-Sforza LL. 20.  2005. The Human Genome Diversity Project: past, present and future. Nat. Rev. Genet. 6:333–40 [Google Scholar]
  21. Chandrasekharan S, Heaney C, James T, Conover C, Cook-Deegan R. 21.  2010. Impact of gene patents and licensing practices on access to genetic testing for cystic fibrosis. Genet. Med. 12:S194–211 [Google Scholar]
  22. Charnas R. 22.  2002. “No patents on life” working group update. Counc. Responsib. Genet. http://www.councilforresponsiblegenetics.org/ViewPage.aspx?pageId=169
  23. Cheon JY, Mozersky J, Cook-Deegan R. 23.  2014. Variants of uncertain significance in BRCA: A harbinger of ethical and policy issues to come?. Genome Med. 6:121 [Google Scholar]
  24. Cho MK, Illangasekare S, Weaver MA, Leonard DGB, Merz JF. 24.  2003. Effects of patents and licenses on the provision of clinical genetic testing services. J. Mol. Diagn. 5:13–8 [Google Scholar]
  25. Cohen JE, Lemley MA. 25.  2001. Patent scope and innovation in the software industry. Calif. Law Rev. 89:1–57 [Google Scholar]
  26. Cohen SN. 26.  2013. DNA cloning: A personal view after 40 years. PNAS 110:15521–29 [Google Scholar]
  27. Colaianni A, Chandrasekharan S, Cook-Deegan R. 27.  2010. Impact of gene patents and licensing practices on genetic testing and carrier screening for Tay-Sachs and Canavan disease. Genet. Med. 12:S5–14 [Google Scholar]
  28. Colliver V. 28.  2013. Ruling on gene patents praised. San Francisco Chronicle June 14, p. A1
  29. 29. Consolidated Appropriations Act 2004. Pub. L. No. 108–199, §634, 118 Stat. 3
  30. 30. Convention on Biodiversity 1992. 1760 UNTS 79; 31 ILM 818
  31. Cook-Deegan R, Heaney C. 31.  2010. Patents in genomics and human genetics. Annu. Rev. Genomics Hum. Genet. 11:383–425 [Google Scholar]
  32. Coughlin SM. 32.  2006. The Newman application and the USPTO's unnecessary response: the patentability of humans and human embryos. 5: Chic.-Kent J. Intell. Prop. 90:105 [Google Scholar]
  33. Crichton M. 33.  2006. Next New York: HarperCollins
  34. Crichton M. 34.  2007. Patenting life. New York Times Feb. 13, p. A23
  35. Czarnetzky JM. 35.  1988. Altering nature's blueprints for profit: patenting multicellular animals. Va. Law Rev. 74:1327–62 [Google Scholar]
  36. 36. D'Arcy v. Myriad Genetics Inc. 2014. FCAFC 115
  37. 37. Diamond v. Chakrabarty 1980.447 US 303
  38. 38. Directive 98/44/EC Eur. Parliament Counc 6th July 1998
  39. 39. Dolan v. City of Tigard. 1994. 512 US 374
  40. 40. ECT Group 1995. US government dumps the Hagahai patent. http://www.etcgroup.org/content/us-government-dumps-hagahai-patent
  41. Eisenberg RS. 41.  1987. Proprietary rights and the norms of science in biotechnology research. Yale Law J. 97:177–231 [Google Scholar]
  42. Eisenberg RS. 42.  2007. The role of the FDA in innovation policy. Mich. Telecom. Technol. Law Rev. 13:345–87 [Google Scholar]
  43. Eisenberg RS. 43.  2012. Patents and regulatory exclusivity. The Oxford Handbook of the Economics of the Biopharmaceutical Industry PM Danzon, S Nicholson 167–98 Oxford, NY: Oxford Univ. Press [Google Scholar]
  44. Locke JC, Larew HG III, Walter JF. 44.  1994. Method for controlling fungi on plants by aid of a hydrophobic extracted neem oil. Eur. Patent No. EP0436257 [Google Scholar]
  45. 45.  File history of U.S.S.N 08/993,564 at Office Action mailed on August 2, 2004
  46. 46. Free the Data 2015. Free the data. Washington, DC: Genet. Alliance http://www.free-the-data.org/clinicians [Google Scholar]
  47. Friedlaender J. 47.  1996. Genes, people, and property: Furor erupts over genetic research on indigenous groups. Cult. Surviv. Q. 20:222–25 [Google Scholar]
  48. Gold ER, Carbone J. 48.  2010. Myriad Genetics: In the eye of the policy storm. Genet. Med. 12:S39–70 [Google Scholar]
  49. Greely HT. 49.  1997. The ethics of the Human Genome Diversity Project: The North American Regional Committee's proposed Model Ethical Protocol. Human DNA: Law and Policy - International and Comparative Perspectives BM Knoppers 239–56 Boston: Kluwer Law Int. [Google Scholar]
  50. Greely HT. 50.  1999. The overlooked ethics of the Human Genome Diversity Project. Polit. Life Sci. 18:297–99 [Google Scholar]
  51. Greely HT. 51.  2001. Human genome diversity: What about the other human genome project?. Nat. Rev. Gen. 2:222–27 [Google Scholar]
  52. Hall JM, Lee MK, Newman B, Morrow JE, Anderson LA. 52.  et al. 1994. Linkage of early-onset familial breast cancer to Chromosome 17q21. Science 250:1684–89 [Google Scholar]
  53. Hanley CJ. 53.  1996. A case of good research or “genetic colonialism.”. Associated Press April 21
  54. Harburg EY, Arlen H. 54.  1939. Ding dong! The witch is dead. The Wizard of Oz Lyrics. http://www.stlyrics.com/lyrics/thewizardofoz/dingdongthewitchisdead.htm
  55. Harry D. 55.  1995. The Human Genome Diversity Project and its implications for indigenous peoples. Information About Intellectual Property Rights No. 6, at Indigenous Peoples Council on Biocolonialism at http://www.ipcb.org/publications/briefing_papers/files/hgdp.html, accessed May 4, 2015 [Google Scholar]
  56. 56. Harvard College v. Canada (Commissioner of Patents) 2002. 4 SCR 45, 2002 SCC 76
  57. Healy B. 57.  1992. On gene patenting. N. Engl. J. Med. 327:664–68 [Google Scholar]
  58. Heled Y. 58.  2014. On patenting human organisms or how the abortion wars feed into the ownership fallacy. Cardozo Law Rev. 36:241–98 [Google Scholar]
  59. Heller MA, Eisenberg RS. 59.  1998. Can patents deter innovation? The anticommons in biomedical research. Science 280:698–701 [Google Scholar]
  60. Hellerer U, Jarayaman KS. 60.  2000. Greens persuade Europe to revoke patent on neem tree. Nature 405:266–67 [Google Scholar]
  61. 61. H.R. 3119, 100th Congr., 1st sess 1987. [Rose bill]
  62. 62. H.R. 4970, 100th Congr., 1st sess 1989. [Kastenmeier bill]
  63. 63. H.R. 977, 110th Congr., 1st sess 2007. [Becerra bill]
  64. 64. In re Allen 1987. 2 USPQ 2d (BNA), 1425 (Board. Patent Appeal Int.)
  65. 65. In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig. 2014. 3 F. Supp. 3d 1213 (D. Utah)
  66. 66. In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig 2014. 774 F.3d 755 (Fed. Cir.)
  67. 67. In re Fisher 2005. 421 F.3d 1365 (Fed. Cir.)
  68. Kevles DJ. 68.  1994. Ananda Chakrabarty wins a patent: biotechnology, law, and society. Hist. Stud. Phys. Biol. Sci. 25:Pt. 1111–35 [Google Scholar]
  69. Khorana HG, Büchi H, Ghosh H, Gupta N, Jacob TM. 69.  et al. 1966. Polynucleotide synthesis and the genetic code. Cold Spring Harb. Symp. Quant. Biol. 31:39–49 [Google Scholar]
  70. Kitch EM. 70.  1986. Patents: monopolies or property rights?. Res. Law Econ. 8:31–49 [Google Scholar]
  71. Kolata G. 71.  2013. DNA project aims to make public a company's data on cancer genes. New York Times April 12, p. A14
  72. Kreeger KY. 72.  1996. Proposed Human Genome Diversity Project still plagued by controversy and questions. Scientist 10:1–8 [Google Scholar]
  73. Leder P, Stewart T. 73.  1985. Transgenic animals. Can Patent No. 1341442
  74. Leder P, Stewart T. 74.  1986. Method for producing transgenic animal. Eur Patent No. EP0169672
  75. Ledford H. 75.  2013. Seed-patent case in Supreme Court. Nature 494:289–90 [Google Scholar]
  76. Lemley MA, Shapiro C. 76.  2007. Patent holdup and royalty stacking. Tex. Law Rev. 85:1991–2049 [Google Scholar]
  77. 77. Mayo Collaborative Services v. Prometheus Laboratories 2012. 566 U.S. ___, 132 S. Ct. 1289
  78. Mehlman MJ. 78.  2004. Moore v. Regents of the University of California. Property Stories. New York: Found. Press., 2nd ed.. [Google Scholar]
  79. Merges R. 79.  1994. Intellectual property rights and bargaining breakdown: the case of blocking patents. Tenn. Law Rev. 62:75–106 [Google Scholar]
  80. Miki Y, Swensen J, Shattuck-Eidens D, Futreal PA, Harshman K. 80.  et al. 1994. A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1. Science 266:66–71 [Google Scholar]
  81. Miller WL. 81.  1979. Use of recombinant DNA technology for the production of polypeptides. Adv. Exp. Med. Biol. 118:153–74 [Google Scholar]
  82. 82. Moore v. Board of Regents of the Univ. of Calif 1990. 51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479
  83. Mossoff A. 83.  2009. Exclusion and exclusive use in patent law. Harv. J. Law Technol. 22:321–79 [Google Scholar]
  84. Mowery DC, Nelson RR, Sampat BN, Ziedonis AA. 84.  2001. The growth of patenting and licensing by US universities: an assessment of the effects of the Bayh-Dole act of 1980. Res. Policy 30:99–119 [Google Scholar]
  85. 85. Natl. Res. Counc. 1997. Intellectual Property Rights and Research Tools in Molecular Biology. Washington, DC: Natl. Acad. Press
  86. 86. Natl. Res. Counc. 2006. Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation and Public Health. Washington, DC: Natl. Acad. Press
  87. 87. Nuffield Counc. Bioethics. 2002. The Ethics of Patenting DNA: A Discussion Paper. London: Nuffield Counc. Bioethics http://nuffieldbioethics.org/project/patenting-dna/
  88. Papadopoulos S. 88.  2003. Evolving paradigms in biotech IPO valuations. Bioentrepreneur. http://www.nature.com/bioent/2003/030101/full/nbt0601supp_BE18.html
  89. 89. Parke-Davis & Co. v. H.K. Mulford. 1911. 189 F. 95 (S.D.N.Y.)
  90. 90. Patents and the Constitution: Hearings Before the Subcomm. on Courts, Civil Liberties and the Administration of Justice of the House Comm. on the Judiciary 1987. 100th Congr., 1st sess. 3
  91. Pieroni JP. 91.  1999. The patentability of expressed sequence tags. Fed. Cir. B. J. 9:401–16 [Google Scholar]
  92. 92. PwC (PriceWaterhouseCoopers) 2014. 2014 Patent Litigation Study: As Case Volume Leaps, Damages Continue General Decline. http://www.pwc.com/en_US/us/forensic-services/publications/assets/2014-patent-litigation-study.pdf
  93. Quigg DJ. 93.  1987. Policy statement on the patentability of animals. 1077 Off. Gaz. Pat. Off. 24 (7 April)
  94. Rimmer M. 94.  2008. Intellectual Property and Biotechnology: Biological Inventions Northampton, MA: Edward Elgar
  95. Riordan T. 95.  1995. Patents: A recent patent on a Papau New Guinea tribe's cell line prompts outrage and charges of “biopiracy.”. New York Times, Nov. 27
  96. Roin BR. 96.  2009. Unpatentable drugs and the standards of patentability. Tex. Law Rev. 87:503–70 [Google Scholar]
  97. Sanger F, Nicklen S, Coulson AR. 97.  1977. DNA sequencing with chain-terminating inhibitors. PNAS 74:5463–67 [Google Scholar]
  98. Schwartz J, Pollack A. 98.  2010. Judge invalidates human gene patents. New York Times March 29, p. B1
  99. 99. Scott Paper Co. v. Marcalus Mfg. Co. 1945. 326 US 811
  100. 100. Secretary's Advisory Committee on Genetics, Health, and Society 2010. Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests Washington, DC: DHHS
  101. 101. Seeking Alpha 2015. Myriad Genetics' (MYGN) CEO Peter Meldrum on Q2 2015 results - earnings call transcript http://seekingalpha.com/article/2881086-myriad-genetics-mygn-ceo-peter-meldrum-on-q2-2015-results-earnings-call-transcript [Google Scholar]
  102. Seymore S. 102.  2010. The teaching function of patents. Notre Dame Law Rev. 85:621–69 [Google Scholar]
  103. Sherkow JS. 103.  2014. The natural complexity of patent eligibility. Iowa Law Rev. 99:1137–96 [Google Scholar]
  104. Siva N. 104.  2009. Myriad wins BRCA1 row. Nat. Biotechnol. 27:8 [Google Scholar]
  105. Skloot R. 105.  2010. The Immortal Life of Henrietta Lacks New York: Crown
  106. Stevens AJ. 106.  2004. The enactment of Bayh-Dole. J. Technol. Transf. 29:93–99 [Google Scholar]
  107. 107.  T 0019/90 (Eur. Patent Off. Board Appeal, Mar. 10, 1980)
  108. 108.  T 0315/03 (Eur. Patent Off. Board Appeal, June 7, 2004)
  109. Tavtigian SV, Simard J, Rommens J, Couch F, Shattuck-Eidens D. 109.  et al. 1996. The complete BRCA2 gene and mutations in chromosome 13q-linked kindreds. Nat. Genet. 12:333–37 [Google Scholar]
  110. Terry S. 110.  2010. Why banning patents would hurt patients. GeneWatch 5:2 http://www.councilforresponsiblegenetics.org/genewatch/GeneWatchPage.aspx?pageId=300 [Google Scholar]
  111. 111. The Use of Human Biological Materials in the Development of Biomedical Products: Hearings Before the Subcomm. on Investigations and Oversight of the House Comm. on Science and Technology 1985. 99th Congr., 1st sess. 241
  112. 112. US Congr., Off. Technol. Assess. 1989. New Developments in Biotechnology: Ownership of Human Tissues and Cells – Spec. Rep. OTA-BA-337 Washington, DC: GPO
  113. 113. US Food Drug Adm 2014. Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) [Google Scholar]
  114. 114. US Food Drug Adm 2014. FDA approves Lynparza to treat advanced ovarian cancer. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427554.htm.
  115. 115. US National Institutes of Health 1998. Report of the National Institutes of Health (NIH) Working Group on Research Tools Bethesda, MD: US NIH. https://www.mmrrc.org/about/NIH_research_tools_policy/, accessed May 4, 2015 [Google Scholar]
  116. Gorana HG. 116.  1957. Synthesis of nucleoside phosphates. US Patent No. 2795580
  117. Heidelberger C, Duschlasky R. 117.  1957. 5-Fluorouracil. US Patent No. 2802005
  118. Spiegelman S, Haruna I. 118.  1972. Synthesis in vitro of nucleic acids and products used therein and products produced therefrom. US Patent No. 3661893
  119. Jachertz D. 119.  1974. Process for the enzymatic reproduction of informationally active RNA. US Patent No. 3785926
  120. Fare LR, Goore M, Naylor JF III, Valenta JR. 120.  1974. Antiviral complex of RNA and polysaccharide. US Patent No. 3821193
  121. Cohen SN, Boyer HW. 121.  1980. Process for producing biologically functional molecular chimera. US Patent No. 4237224
  122. Manis JJ. 122.  1981. Plasmid and process of isolating same. US Patent No. 4273875
  123. Wu RJ, Bahl CP, Narang SA. 123.  1982. Oligonucleotides useful as adaptors in DNA cloning, adapted DNA molecules, and methods of preparing adaptors and adapted molecules. US Patent No. 4321365
  124. Brassfield RW. 124.  1982. Airlift type dredging apparatus. US Patent No. 4322897
  125. Bos WA. 125.  1982. Cutter head with adjustable suction nozzle. US Patent No. 4322898
  126. Goodman HM, Shine J, Seeburg PH. 126.  1982. Recombinant DNA transfer vectors. US Patent No. 4363877
  127. Olsen RH. 127.  1983. DNA fragments for forming plasmids. US Patent No. 4418194
  128. Roland J, Reppelin M, Seigneurin L. 128.  1984. Preparation of aromatic(aliphatic nitriles. US Patent No. 4438042
  129. Olsen RH. 129.  1985. Molecular cloning vectors for use in gram-negative bacteria. US Patent No. 4508827
  130. Leder P, Stewart TA. 130.  1988. Transgenic non-human mammals. US Patent No. 4736866
  131. 131.  US Patent Appl. No. 08/933,564 (submitted Dec. 18, 1997)
  132. 132. US Patent Trademark Off 1998. Facts on patenting life forms having a relationship to humans. http://www.uspto.gov/about-us/news-updates/facts-patenting-life-forms-having-relationship-humans
  133. von der Ropp A, Taubman T. 133.  2006. Bioethics and patent law: The case of Myriad. WIPO Mag 2006:48–9 [Google Scholar]
  134. Werth B. 134.  2013. A tale of two drugs. Technol. Rev. Oct. 22
  135. Whoriskey P. 135.  2009. Monsanto's dominance draws antitrust inquiry. Washington Post Nov. 29
  136. 136. Wired 1999. Genentech pays off UCSF. Wired. http://archive.wired.com/science/discoveries/news/1999/11/32655
  137. Wooster R, Bignell G, Lancaster J, Swift S, Seal S. 137.  et al. 1995. Identification of the breast cancer susceptibility gene BRCA2. Nature 378:789–92 [Google Scholar]
  138. Wooster R, Neuhausen SL, Mangion J, Quirk Y, Ford D. 138.  et al. 1994. Localization of a breast cancer susceptibility gene, BRCA2, to chromosome 13q12–13. Science 265:2088–90 [Google Scholar]
  139. Wyatt E. 139.  2013. Obama orders regulators to root out patent trolls. New York Times June 4, p. B1 [Google Scholar]
/content/journals/10.1146/annurev-genet-112414-054731
Loading
  • Article Type: Review Article
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error